Medical Director Clinical Science

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

Role & Function

The Medical Director Clinical Science is responsible for Sobi’s clinical development activities and serves as scientific and medical expert on matters relating to the assigned development program including operational, regulatory and drug safety. This is a US based role.

Key Responsibilities

• Provide clinical, scientific, and strategic input to clinical development plans and activities, while adhering to the highest scientific and ethical standards ensuring for success
• Act as Medical Director responsible for Sobi-sponsored studies.
• Responsibility for planning, designing, conducting (including medical monitoring) and reporting Sobi-sponsored studies, in close collaboration with the Medical Development Lead (MDL), Medical Program Lead (MPL) and other MACS members, clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.
• Member of the Medical Development Team and of Clinical Study Team(s) and collaborate with the Medical Development Lead for scientific and medical development strategy.
• Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications.
• Responsible to development of clinical study protocols and reports and contribute to the statistical analysis plans, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriate
• Provide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products/projects, as requested and appropriate.
• Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority’s questions to support e.g., scientific advice, IND application, marketing authorization.
• Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.
• To be successful in these activities, the Medical Director, Clinical Science will possess and continue to develop significant level of knowledge in assigned therapeutic area. Will develop productive relationships and contributions within the cross-functional headquarter team, as well as with local affiliate offices, and collaborative partners. Will role model the highest scientific and ethical standards, and work in accordance with applicable rules and regulations with regards to scientific and medical activities.

Qualifications

• Medical Degree required.  At least 4 years clinical experience treating patients (rheumatology/immunology preferred) and/or at least 10 years of solid record of accomplishment within rheumatology/immunology drug development programs demonstrating outstanding and intimate understanding of various phases of clinical trials
• Therapeutic and/or clinical trial experience with sirolimus and uricase enzymes preferred
• Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making
• Good communication skills, capable of representing the company to all audiences both internally and externally, particularly in the context of collaborations at international conferences and scientific symposia
• Good organizational skills, be a self-motivated driver of best practices and processes in t